A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624

NCT05378893 | Completed Phase 1

• 1 other identifier: DR10624-101
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. The objectives of the planned clinical investigation will be to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending doses of DR10624 via subcutaneous (SubQ) injection in a randomized, placebo-controlled, double-blind study.

Conditions

Healthy, Obesity, Metabolically

Outcome Measures

Primary Outcomes (1)

• Number of participants with one or more treatment-emergent adverse event (TEAE), serious adverse event (SAE) and adverse event of special interest (AESI).

  Number of participants with one or more TEAE, SAE and AESI.

  baseline through day 29(part 1)or day 106(part 2)

Secondary Outcomes (30)

• Area under the serum concentration versus time curve (AUC)

  baseline through day 29(part 1)or day 106(part 2)

• Maximum observed serum concentration (Cmax)

  baseline through day 29(part 1)or day 106(part 2)

• Time to reach maximum observed serum concentration (Tmax)

  baseline through day 29(part 1)or day 106(part 2)

• Terminal elimination half-life (t1/2)

  baseline through day 29(part 1)or day 106(part 2)

• Mean residence time (MRT)

  baseline through day 29(part 1)or day 106(part 2)

Study Arms (4)

Single-ascending dose：Part1：DR10624

EXPERIMENTAL

Escalating doses of DR10624 for injection administered subcutaneously in healthy participants or obese but otherwise healthy participants

Drug: DR10624 for injection

Single-ascending dose：Part1：placebo

PLACEBO COMPARATOR

Escalating doses of placebo for injection administered subcutaneously in in healthy participants or obese but otherwise healthy participants

Drug: Placebo

Multiple-ascending dose：Part2：DR10624

EXPERIMENTAL

Escalating doses of DR10624 for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia

Drug: DR10624 for injection

Multiple-ascending dose：Part2：placebo

PLACEBO COMPARATOR

Escalating doses of placebo for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia

Drug: Placebo

Interventions

DR10624 for injection DRUG

administered via subcutaneous injection

Multiple-ascending dose：Part2：DR10624; Single-ascending dose：Part1：DR10624

Placebo DRUG

administered via subcutaneous injection

Multiple-ascending dose：Part2：placebo; Single-ascending dose：Part1：placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
• Female subjects (heterosexually active, of childbearing potential, not pregnant, not trying to become pregnant, and not lactating) are eligible to participate if they agree to total abstinence from heterosexual intercourse or use a highly effective method of birth control listed below, from screening through until at least 30 days after the last dose of the study drug.
• Male subjects with female partners of childbearing potential are eligible to participate if they are vasectomized, or agree to total abstinence from heterosexual intercourse, from screening through until at least 30 days after the last study dose, or use of an effective method of birth control listed above, from screening through until at least 30 days after the last study dose. Male subjects must refrain from sperm donation throughout the study and for 30 days after the last study dose.
• The subject agrees to comply with all protocol requirements.
• The subject is able to provide written informed consent.
• The subject is male or female 18 to 55 years of age, inclusive.
• The subject has a body weight ≥50 kg at screening and a BMI of 18 to 32 kg/m2, inclusive, or.
• The subject has a BMI of 30 to 40 kg/m2, inclusive, at screening in obesity subjects cohort.
• The subject is male or female 18 to 60 years of age, inclusive.
• The subject has a BMI of 30 to 45 kg/m2 at screening, inclusive.
• Fasting triglyceride ≥150 mg/dL (1.7 mmol/L), and \<500 mg/dL (5.7 mmol/L), at screening.

You may not qualify if:

• The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
• The subject has a personal or family history of medullary thyroid cancer, or multiple endocrine neoplasia syndrome Type 2, or a screening calcitonin ≥50 ng/L.
• The subject has a history of chronic pancreatitis or episode of acute pancreatitis within 3 months of screening.
• In Part 1, the subject has used any prescription medications (excluding oral contraceptives, paracetamol, and ibuprofen) within 14 days before the first dose of study drug. In Part 2, the subjects have been on stable lipid-lowering therapy \<8 weeks before the first dose of study drug.
• The subject has consumed alcohol within 48 hours before dosing or during the confinement period.
• The subject is a smoker or has used tobacco, nicotine, or nicotine-containing products.
• The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption.
• The subject has a positive test result for drugs of abuse and/or alcohol abuse at screening and check-in for the first inpatient period.
• The subject is involved in strenuous activity or contact sports within 48 hours before admission.
• The subject has donated blood or blood products \>450 mL within 30 days before the first dose of study drug.
• The subject has total cholesterol \>10.3 mmol/L or triglycerides ≥5.7 mmol/L (500 mg/dL) at screening.
• The subject has clinically significant history or presence of ECG findings as determined by the investigator at screening and check-in,
• \- Uncontrolled hypertension (defined as systolic blood pressure (SBP) ≥160 mmHg, and/or diastolic blood pressure (DBP) ≥100 mmHg), angina, bradycardia (if assessed as clinically significant by the investigator), or severe peripheral arterial circulatory disorders.
• The subject has a history of relevant drug and/or food allergies (ie, allergy to DR10624 or excipients, or any significant food allergy that could preclude a standard diet in the clinical unit).
• The subject has a history of severe allergic or anaphylactic reactions.

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (1)

New Zealand Clinical Research

Christchurch, Canterbury, 8011, New Zealand

Location

MeSH Terms

Conditions

Obesity, Metabolically Benign

Interventions

Injections

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Alexandra Cole, DHPharm

  New Zealand Clinical Research (NZCR)

  PRINCIPAL INVESTIGATOR

• Yanshan Huang, PhD

  Zhejiang Doer Biologics Co., Ltd.

  STUDY CHAIR

• Yongliang Fang, PhD

  Zhejiang Doer Biologics Co., Ltd.

  STUDY DIRECTOR

• Junfang Xu, MD

  Huadong Medicine Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: May 18, 2022
• Study Start: June 22, 2022
• Primary Completion: October 10, 2024
• Study Completion: January 31, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)