Type 2 Diabetes MellitusPhase 1NCT02538848
Study of HTD4010 in Healthy Volunteers
A Phase 1 study testing HTD4010 in people with Type 2 Diabetes Mellitus, run by HighTide Therapeutics (Hong Kong) Limited at 1 site in Australia.
Trial summary
To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- HTD4010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
- Non-diabetic, fasting plasma glucose < 5.6 mmol/L
- 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.
- Ability to provide written informed consent.
Who cannot join
- Systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg at screening.
- Pregnant or lactating women
- 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.
- 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.
- Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
- History of any major surgery within 6 months prior to Screening
Show all 9Show fewer
- History of any serious adverse reaction or hypersensitivity to any of the product components.
- Use of parenterally administered proteins or antibodies within 12 weeks of screening.
- etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First in Human, Randomized, Double-Blind Study to Assess Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Effects of HTD4010 in Healthy Participants
To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in healthy volunteers
Read the detailed description
Safety, tolerability and pharmacokinetics(PK) assessments are the outcome measure.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- HTD4010
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTD4010Drug
Also called analog of INGAP peptide
injectable solution
| Study group | Role | What they receive |
|---|---|---|
| 50mg in SAD | Experimental | single dose of 50mg HTD4010 or placebo injectable in healthy volunteers Receives: Drug: HTD4010 |
| 100mg in SAD | Experimental | single dose of 100mg HTD4010 or placebo injectable in healthy volunteers Receives: Drug: HTD4010 |
| 200mg in SAD | Experimental | single dose of 200mg HTD4010 or placebo injectable in healthy volunteers Receives: Drug: HTD4010 |
| 300mg in SAD | Experimental | single dose of 300mg HTD4010 or placebo injectable in healthy volunteers Receives: Drug: HTD4010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and causality of adverse events
Measured: One day in SAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- HighTide Therapeutics (Hong Kong) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janakan Krishnarajah, Doctor, Principal investigator, Linear Clinical Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538848
- Sponsor's protocol ID
- 4010.PCT001
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2015
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human, Randomized, Double-Blind Study to Assess Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Effects of HTD4010 in Healthy Participants
- ClinicalTrials.gov ID
- NCT02538848
- Acronym / sponsor ID
- 4010.PCT001
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- HighTide Therapeutics (Hong Kong) LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in healthy volunteers
Detailed description
Safety, tolerability and pharmacokinetics(PK) assessments are the outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50mg in SAD | Experimental | Drug: HTD4010single dose of 50mg HTD4010 or placebo injectable in healthy volunteers |
| 100mg in SAD | Experimental | Drug: HTD4010single dose of 100mg HTD4010 or placebo injectable in healthy volunteers |
| 200mg in SAD | Experimental | Drug: HTD4010single dose of 200mg HTD4010 or placebo injectable in healthy volunteers |
| 300mg in SAD | Experimental | Drug: HTD4010single dose of 300mg HTD4010 or placebo injectable in healthy volunteers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
- Non-diabetic, fasting plasma glucose < 5.6 mmol/L
- 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.
- Ability to provide written informed consent.
Key exclusion criteria (9 listed)
- Systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg at screening.
- Pregnant or lactating women
- 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.
- 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.
- Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTD4010Also: analog of INGAP peptideinjectable solution | Drug | 100mg in SAD, 200mg in SAD, 300mg in SAD, 50mg in SAD |
Primary outcome
Incidence, severity and causality of adverse events
Time frame: One day in SAD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janakan Krishnarajah, Doctor principal investigator
Linear Clinical Research Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HTD4010 in people with Type 2 Diabetes Mellitus, run by HighTide Therapeutics (Hong Kong) Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and causality of adverse events (time frame: One day in SAD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.