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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02538848




Registration number
NCT02538848
Ethics application status
Date submitted
31/08/2015
Date registered
2/09/2015
Date last updated
7/06/2016

Titles & IDs
Public title
Study of HTD4010 in Healthy Volunteers
Scientific title
A First in Human, Randomized, Double-Blind Study to Assess Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Effects of HTD4010 in Healthy Participants
Secondary ID [1] 0 0
4010.PCT001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HTD4010

Experimental: 50mg in SAD - single dose of 50mg HTD4010 or placebo injectable in healthy volunteers

Experimental: 100mg in SAD - single dose of 100mg HTD4010 or placebo injectable in healthy volunteers

Experimental: 200mg in SAD - single dose of 200mg HTD4010 or placebo injectable in healthy volunteers

Experimental: 300mg in SAD - single dose of 300mg HTD4010 or placebo injectable in healthy volunteers


Treatment: Drugs: HTD4010
injectable solution

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

Outcomes
Primary outcome [1] 0 0
Incidence, severity and causality of adverse events
Timepoint [1] 0 0
One day in SAD

Eligibility
Key inclusion criteria
For volunteers in SAD:



1. Body mass index (BMI) =18.0 to = 30.0 kg/m2

2. Non-diabetic, fasting plasma glucose < 5.6 mmol/L

3. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g.,
tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or
post-menopausal for =12 months.

Males must be surgically sterile, abstinent or if engaged in sexual relations of
child-bearing potential, the participant and his partner must be using an acceptable,
highly effective, contraceptive method from screening and for a period of 60 days
after the last dose of Study Drug.

4. Ability to provide written informed consent.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg at
screening.

2. Pregnant or lactating women

3. Participation in an investigational study within 30 days prior to dosing or 5
half-lives within the last dose of investigational product whichever is longer.

4. Current use of any prescription or over-the-counter (OTC) medications, including
herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives,
whichever is longer. Use of =2g paracetamol per day is allowed prior to and during the
study at Investigator discretion.

5. Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.

6. History of any major surgery within 6 months prior to Screening

7. History of any serious adverse reaction or hypersensitivity to any of the product
components.

8. Use of parenterally administered proteins or antibodies within 12 weeks of screening.

etc.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
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
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)
Recruitment hospital [1] 0 0
Linear Clinical Research Limited - Perth
Recruitment postcode(s) [1] 0 0
WA6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
HighTide Biopharma Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in
healthy volunteers
Trial website
https://clinicaltrials.gov/show/NCT02538848
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janakan Krishnarajah, Doctor
Address 0 0
Linear Clinical Research Limited
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