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Completed

NCT Number: NCT06427590

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects

This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.

This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ascletis

Herston, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key inclusion Criteria:

  • Subject have provided informed consent before initiation of any study-specific procedures
  • Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
  • Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.

Key exclusion Criteria:

  • Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
  • Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
  • Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
  • Have a history of febrile illness within 14 days prior to screening.
  • Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
  • Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
  • Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.

Treatment and study plan

ASC47

Drug

single subcutaneous injection of ASC47

Matching Placebo

Drug

single subcutaneous injection of Placebo

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: up to 57 days

    Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.

  2. ECG QT Interval

    Time frame: up to 57 days

    Evaluate the ECG QT Interval after single doses of ASC47.

  3. Blood cell

    Time frame: up to 57 days

    Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.

  4. Hematology

    Time frame: up to 57 days

    Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.

Secondary outcomes

  1. AUC of ASC47

    Time frame: up to 57 days

    Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.

  2. Cmax of ASC47

    Time frame: up to 57 days

    Evaluate the Peak Plasma Concentration after single doses of ASC47.

  3. Cmin of ASC47

    Time frame: up to 57 days

    Evaluate the Minimum Plasma Concentration after single doses of ASC47.

  4. T1/2 of ASC47

    Time frame: up to 57 days

    Evaluate the Terminal-Phase Half-Life after single doses of ASC47

  5. CL/F of ASC47

    Time frame: up to 57 days

    Evaluate the Apparent Systemic Clearance after single doses of ASC47.

  6. Vd/F of ASC47

    Time frame: up to 57 days

    Evaluate the Apparent Volume of Distribution after single doses of ASC47.

  7. Lipid parameters

    Time frame: up to 57 days

    Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.

Sponsors and collaborators

Lead sponsor

Ascletis Pharma (China) Co., Limited

Industry

Registry information

Official study title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy and Obese Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 24, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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