Study of HTD4010 in Healthy Volunteers

A First in Human, Randomized, Double-Blind Study to Assess Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Effects of HTD4010 in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02538848

Enrollment

Registered

2015-09-02

Start date

2015-10-01

Completion date

2016-03-01

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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.

Interventions

DRUGHTD4010

injectable solution

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

For volunteers in SAD: Inclusion Criteria: 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.

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.

Design outcomes

Primary

Measure	Time frame
Incidence, severity and causality of adverse events	One day in SAD

Countries

Australia

Contacts

PRINCIPAL_INVESTIGATORJanakan Krishnarajah, Doctor

Linear Clinical Research Limited

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026