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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05022771




Registration number
NCT05022771
Ethics application status
Date submitted
20/08/2021
Date registered
26/08/2021
Date last updated
31/01/2023

Titles & IDs
Public title
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015
Scientific title
A Phase 1A, First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 in Healthy Volunteers
Secondary ID [1] 0 0
PMG1015-AUS-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PMG1015 Dose 1
Treatment: Drugs - PMG1015 Dose 2
Treatment: Drugs - PMG1015 Dose 3
Treatment: Drugs - PMG1015 Dose 4
Treatment: Drugs - PMG1015 Dose 5
Treatment: Drugs - PMG1015 Dose 6
Treatment: Drugs - Placebo
Treatment: Drugs - PMG1015 Dose 7

Experimental: Single Ascending Doses Cohort 1a - Subjects will receive either Dose level 1 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1b - Subjects will receive either Dose level 2 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1c - Subjects will receive either Dose level 3 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1d - Subjects will receive either Dose level 4 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1e - Subjects will receive either Dose level 5 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1f - Subjects will receive either Dose level 6 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1g - Subjects will receive either Dose level 7 of PMG1015 or Placebo


Treatment: Drugs: PMG1015 Dose 1
Dose level 1 of PMG1015

Treatment: Drugs: PMG1015 Dose 2
Dose level 2 of PMG1015

Treatment: Drugs: PMG1015 Dose 3
Dose level 3 of PMG1015

Treatment: Drugs: PMG1015 Dose 4
Dose level 4 of PMG1015

Treatment: Drugs: PMG1015 Dose 5
Dose level 5 of PMG1015

Treatment: Drugs: PMG1015 Dose 6
Dose level 6 of PMG1015

Treatment: Drugs: Placebo
Placebo to match

Treatment: Drugs: PMG1015 Dose 7
Dose level 7 of PMG1015
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The incidence of Treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Day 1-Day 85
Primary outcome [2] 0 0
The severity of Treatment-emergent adverse events (TEAEs)
Timepoint [2] 0 0
Day 1-Day 85
Primary outcome [3] 0 0
The incidence of Serious adverse events (SAEs)
Timepoint [3] 0 0
Day 1-Day 85
Primary outcome [4] 0 0
The severity of Serious adverse events (SAEs)
Timepoint [4] 0 0
Day 1- Day 85
Primary outcome [5] 0 0
Number of participants with abnormally clinical vital signs
Timepoint [5] 0 0
Day 1- Day 85
Primary outcome [6] 0 0
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Timepoint [6] 0 0
Day 1-Day 85.
Primary outcome [7] 0 0
Number of participants with abnormal clinically significant clinical laboratory results
Timepoint [7] 0 0
Day 1- Day 85
Primary outcome [8] 0 0
MTD of PMG1015 in healthy participants
Timepoint [8] 0 0
Day 1- Day 85
Primary outcome [9] 0 0
Number of patients with abnormal clinically significant results from physical examination
Timepoint [9] 0 0
Day 1-Day 85
Secondary outcome [1] 0 0
Area under the serum-concentration time curve (AUC) from time zero (from the start of infusion time) to the last time point with measurable analyte concentration (AUC0-t)
Timepoint [1] 0 0
Day 1-Day 85.
Secondary outcome [2] 0 0
AUC from time zero to infinity (AUC0-8)
Timepoint [2] 0 0
Day 1-Day 85.
Secondary outcome [3] 0 0
To determine %AUCexp
Timepoint [3] 0 0
Day 1-Day 85.
Secondary outcome [4] 0 0
To determine Cmax
Timepoint [4] 0 0
Day 1-Day 85.
Secondary outcome [5] 0 0
To determine Tmax, derived from serum concentration of each dose of PMG1015
Timepoint [5] 0 0
Day 1-Day 85.
Secondary outcome [6] 0 0
To determine t1/2
Timepoint [6] 0 0
Day 1-Day 85.
Secondary outcome [7] 0 0
Apparent total body clearance (CL)
Timepoint [7] 0 0
Day 1-Day 85.
Secondary outcome [8] 0 0
Apparent volume of distribution during the terminal phase (Vz)
Timepoint [8] 0 0
Day 1-Day 85.
Secondary outcome [9] 0 0
Apparent terminal elimination rate constant (?z or kel)
Timepoint [9] 0 0
Day 1-Day 85.
Secondary outcome [10] 0 0
Levels of ADA
Timepoint [10] 0 0
Day 1-Day 85

Eligibility
Key inclusion criteria
1. Healthy male or non-pregnant, non-lactating female volunteers, between 18 and 60 years
of age, inclusive at the time of informed consent.

2. Body mass index (BMI) between 17.5 and 32.0 kg/m2 (inclusive) and body weight between
50 and 100 kg for males and between 45 and 100 kg for females.

3. No clinically significant clinical laboratory values (Hematology, coagulation,
biochemistry and urinalysis) at the discretion of the PI.

4. Females of child bearing potential must use an acceptable, highly effective double
contraception and have a negative pregnancy test at Screening and Day-1.

5. Documented evidence of surgical sterilization at least 6 months prior to screening for
women or vasectomy at least 90 days prior to screening.

6. Women not of child bearing potential must be menopausal for >/= 12 months.

7. Males must not donate sperms for at least 90 days after PMG1015 administration.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or evidence of clinically significant condition, including but not limited to
any cardiovascular, gastrointestinal, endocrinologic, hematologic, psychiatric, renal
disease, musculoskeletal, infectious, or neurological condition or any chronic medical
condition and/or other major disease, as determined by the PI.

2. A PR < 40 or > 100 beats per minute, mean systolic blood pressure (SBP) > 140 mmHg, or
mean diastolic blood pressure (DBP) > 95 mmHg .

3. A mean corrected QT interval using Fridericia's formula (QTcF) interval at Screening >
450 ms in males and > 470 ms in females. If the mean QTcF exceeds these limits, one
additional triplicate ECG will be performed.

4. Any clinically significant abnormalities in rhythm, conduction, or morphology of the
resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the PI,
may interfere with the interpretation of QTc-interval changes, including abnormal ST-T
wave morphology or left ventricular hypertrophy.

5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine > 1.5
× the upper limit of the normal range (ULN) or total bilirubin or lymphocyte counts >
ULN.

6. Participants with a positive toxicology screening panel or alcohol breath test on
Screening/Day-1.

7. Participants with a history of substance abuse or dependency or history of
recreational IV drug use over the last 2 years.

8. Plasma donation/Blood donation or significant blood loss within 60 days prior to the
first IP administration.

9. Use of any IP (including other investigational mAb products) or investigational
medical device within 30 days prior to Screening or 5 half-lives of the product
(whichever is the longest) or participation in more than 4 investigational drug
studies within 1 year prior to screening.

10. Major surgery (general anesthetic) within 3 months or minor surgery (local anesthetic)
within 1 month prior to IP administration, or planned surgery during the study period,
which is determined by the PI to be clinically relevant.

11. Fever or symptomatic bacterial or viral infection.

12. Participants who have received live vaccines or attenuated vaccines within 1 month
before dosing.

13. Participants with any active malignancy or history of malignancy within 5 years prior
to enrolment.

14. Use of any other prescription medications.

15. History of anaphylaxis, allergic reactions to the excipients of IP, asthma.

16. Positive blood screen for HIV1/2 antibody, Hepatitis B surface antigen, hepatitis C
virus, or syphilis at screening.

17. Participants with an inability to tolerate venous access.

18. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at
any time during the study, including the follow-up period.

19. An employee of Pulmongene or Novotech (Australia) Pty Ltd.

20. Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission
to the CRU and while resident at the CRU.

21. Any other condition or finding that in the opinion of the PI or designee would put the
participant or study conduct at risk.

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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2022
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd, Clive Berghofer Cancer Research Centre - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pulmongene Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose
escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody,
being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary
fibrosis (IPF). This study aims to evaluate the safety, tolerability, pharmacokinetics and
immunogenicity of PMG1015 after Single ascending doses (SAD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05022771
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Friend
Address 0 0
Nucleus Network
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