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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04505137




Registration number
NCT04505137
Ethics application status
Date submitted
31/07/2020
Date registered
10/08/2020
Date last updated
12/11/2020

Titles & IDs
Public title
A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers
Scientific title
A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of A Single Intravenous Dose Of GMA301 Injection In Healthy Volunteers
Secondary ID [1] 0 0
GETA_SAD_02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GMA301 Injection
Other interventions - GMA301 Placebo Injection
Treatment: Drugs - GMA301 Injection

Experimental: GMA301 1500mg Or Placebo Injection - Two sentinel subjects (1 active and 1 placebo) will be dosed first and then reaming 6 subjects will dosed within 7 days. The dose to be administered is 1500 mg single Intravenous dose of GMA301 Injection.

Experimental: GMA301 2000mg Or Placebo Injection - Two sentinel subjects (1 active and 1 placebo) will be dosed first and then reaming 6 subjects will dosed within 7 days. The dose to be administered is 2000 mg single intravenous dose of GMA301 Injection.


Treatment: Drugs: GMA301 Injection
GMA301 Injection administered as a single dose of 1500 mg

Other interventions: GMA301 Placebo Injection
GMA301 Injection without GMA301 administered as a single intravenous dose

Treatment: Drugs: GMA301 Injection
GMA301 Injection administered as a single dose of 2000 mg

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability - To assess the safety and tolerability of GMA301 Injection following single escalating intravenous (IV) injections in healthy subjects.
Timepoint [1] 0 0
All AEs (adverse events) will be captured from the time the investigator received the signed ICF (informed consent form) of subjects until study completion ie Day 70
Secondary outcome [1] 0 0
Pharmacokinetics Profile - PK parameters determined is AUC(0-inf)
Timepoint [1] 0 0
Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Secondary outcome [2] 0 0
Pharmacokinetics Profile - PK parameters determined is AUC(0-t)
Timepoint [2] 0 0
Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Secondary outcome [3] 0 0
Pharmacokinetics Profile - PK parameters determined is C(max)
Timepoint [3] 0 0
Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Secondary outcome [4] 0 0
Pharmacokinetics Profile - PK parameters determined is residual area
Timepoint [4] 0 0
Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Secondary outcome [5] 0 0
Pharmacokinetics Profile - PK parameters determined is T(max)
Timepoint [5] 0 0
Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Secondary outcome [6] 0 0
Pharmacokinetics Profile - PK parameters determined is T(1/2 el)
Timepoint [6] 0 0
Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Secondary outcome [7] 0 0
Pharmacokinetics Profile - PK parameters determined is K(el)
Timepoint [7] 0 0
Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Secondary outcome [8] 0 0
Dose for GMA301 Injection for subsequent clinical studies - To identify appropriate doses of GMA301 Injection for subsequent clinical studies
Timepoint [8] 0 0
All AEs will be captured from the time the investigator received the signed ICF of subjects until study completion ie Day 70

Eligibility
Key inclusion criteria
1. Non-smoker (no use of tobacco or nicotine products within 2 months prior to screening)
with BMI > 18.5 and < 30.0 kg/m2 and body weight = 50.0 kg for males and = 45.0 kg for
females. Each cohort will include at least 2 participants of Chinese descent, if
possible.

2. Healthy as defined by:

1. The absence of clinically significant illness and surgery within 4 weeks prior to
dosing.

2. The absence of clinically significant history of neurological, endocrine,
cardiovascular, respiratory, hematological, immunological, psychiatric,
gastrointestinal, renal, hepatic, and metabolic disease.

3. Females of childbearing potential who are sexually active with a male partner must be
willing to use one of the following acceptable contraceptive methods throughout the
study and for 6 months after the last study drug administration:

1. Oral, injected, or implanted hormonal methods of contraception in combination
with a barrier method;

2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) in
combination with a barrier method;

3. Sterilized male partner (with the appropriate post-vasectomy documentation of the
absence of sperm in the ejaculate) in combination with a barrier method;

4. True abstinence, when this is in line with the subject's preferred and usual
lifestyle.

4. Male subjects must agree to avoid causing pregnancy by using a reliable method of
birth control during the study and for 6 months after study drug administration and
must be willing to use one of the following acceptable contraceptives:

1. Simultaneous use of a male condom and, for the female partner, hormonal
contraceptives used since at least 4 weeks or intra-uterine contraceptive device
placed since at least 4 weeks;

2. Simultaneous use of a male condom and, for the female partner, a diaphragm or
cervical cap.

5. Male subjects (including men who have had a vasectomy) with a pregnant partner must
agree to use a condom from the first study drug administration until at least 6 months
after study drug administration.

6. Male subjects must be willing not to donate sperm during the study and for 6 months
following study drug administration.

7. Capable of consent.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormality at physical examination, clinically significant
abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C
found during medical screening.

2. Presence or history of any clinically significant chronic condition of the
neurological, respiratory, cardiovascular, gastrointestinal, urogenital, reproductive,
musculoskeletal, endocrine system or cancer.

3. Clinically significant (as judged by the investigator) presence of acute illness
(e.g., gastrointestinal illness, infection such as influenza, upper respiratory tract
infection) upo admission to the study site.

4. Alanine aminotransferase and/or aspartate aminotransferase above the upper limit of
normal.

5. Positive urine drug screen or alcohol breath test at screening.

6. Positive pregnancy test at screening.

7. Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood
pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 60 or
over 90 mmHg,or heart rate less than 40 or over 100 bpm) at screening. Up to 2
additional measurements may be taken after an appropriate resting interval (at least
10 minutes) at Screening to confirm eligibility.

8. History of type 1 hypersensitivity or severe cutaneous adverse reaction to any
medication, or to any excipient in the formulation, or history of significant atopy.

9. Hemoglobin below lower limit of normal.

10. Women who intend to become pregnant or are lactating.

11. History of significant alcohol abuse within 1 year prior to screening or regular use
of alcohol within 6 months prior to the screening visit (average weekly alcohol intake
that exceeds 14 units per week (males) or 7 units (females) per week, or are unwilling
to stop alcohol consumption for 24 hours prior to study drug dosing until the
completion of the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine;1.5
oz or 45 mL of distilled spirits).

12. History of significant drug abuse within 1 year prior to screening or use of soft
drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs
(such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and
amphetamine derivatives) within 1 year prior to screening.

13. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to dosing,
administration of a biological product in the context of a clinical research study
within 90 days prior to dosing, or concomitant participation in an investigational
study involving no drug or device administration.

14. Use of prescription medications or over-the-counter medications within 7 days prior to
study drug administration, with the exception of simple analgesics such as paracetamol
and routine vitamins.

15. Donated more than 500 mL of blood within 4 weeks prior to study enrollment, or donated
plasma or participated in a plasmapheresis program within 7 days of study drug
administration.

16. Any reason which, in the opinion of the Investigator, would prevent the subject from
participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gmax Biopharm Australia Pty Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Metaclinical
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Syneos Heath
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is a single-centre, randomized, double-blind, placebo-controlled, dose escalation
study to assess the safety, tolerability and PK of GMA301 Injection in healthy subjects. Two
sequential dosing cohorts (at ascending dose fashion), each with 6 subjects receiving GMA301
Injection and 2 subjects receiving placebo (total of 16 subjects), will be given single
doses. The doses to be administered in the two cohorts will be 1500 mg and 2000 mg
respectively, or matching placebo
Trial website
https://clinicaltrials.gov/show/NCT04505137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sepehr Shakib, Dr
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications