A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants (NCT06504043) | Clinical Trial Compass
By InvitationPhase 1
A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
China30 participantsStarted 2024-09-17
Plain-language summary
This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated LDL-C Levels.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Men and women who are ≥18 and ≤55 years of age with elevated LDL-C Levels;
* LDL-C ≥ 2.6 mmol/L (100 mg/dL) and ≤ 4.9 mmol/L (190 mg/dL) and TG ≤ 2.83 mmol/L (250 mg/dL) who are not on a lipid-lowering therapy 30 days prior to screening;
* Body mass index (BMI) ≥18 and≤28 kg/m2
Exclusion Criteria:
* Positive blood screen for HIV antibody, Treponema pallidum antibody, HBsAg or HCV antibody;
* Clinically significant liver function test abnormalities at screening, such as AST or ALT \> 2 Ă— ULN, total bilirubin \> 1.5 Ă— ULN, or ALP \> 2 Ă— ULN based on normal values;
* CK \> 3 Ă— ULN at the screening visit, it can be retested if considered to be related to exercise;
* History of prescription drug abuse, illicit drug use or alcohol abuse;
* Use of any prescription drug, herbal and compound decoction, vitamins, minerals, and OTC drugs and nutritional supplements that alter lipid metabolism within 14 days prior to Check-in and planned use of the above drugs throughout the study;
* Prior treatment with PCSK9 inhibitors, including mAbs, siRNA products, or any Adnectin products;
* History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine;
* Less than 30 days or less than 5 half-lives (drug) since the end of participation in another clinical trial (drug or device), whichever is longer;
* Use of any other biologics within 3 months prior to investigational product administration;
* Any other significant clinical diseases or psycho…
What they're measuring
1
The primary objective of this study is to assess the safety and tolerability of a single SC dose of HST101 in Chinese healthy adult study participants with elevated LDL-C level(International Standard Unit: mmol/L)