Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT06022536

A Clinical Study of SSS40 in Healthy Chinese Volunteers

Healthy Clinical Trial

Official title:
SSS40 A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study of Single-dose, Dose-escalation Safety, Tolerability, Pharmacokinetics, and Immunogenicity in Healthy Chinese Subjects.

Clinical Trial Summary

This is a single-center, randomized, double-blind, single-administration, escalating-dose, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of SSS40 in healthy subjects in China. A total of 8 subcutaneous dose groups were planned, including 1mg, 3mg, 10mg, 20mg, 30mg, 45mg, 60mg, 80mg. Starting from the 10mg group, a sentinel approach was adopted, whereby 2 subjects were first enrolled in the group, and randomized to the sentinel group in a 1:1 ratio (test drug:placebo), with the sentinels blinded, and then the remaining subjects in the group were randomized according to a 1:1 ratio (test drug:placebo), and the sentinel group was blinded. After completion of the 72-h safety assessment in the sentinel group, the remaining subjects in the group were randomized to receive the drug according to the test drug group and the placebo group.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06022536
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact Yu Cao, doctor
Phone 86-18661809090
Email caoyu1767@126.com
Status Not yet recruiting
Phase Phase 1
Start date August 28, 2023
Completion date July 12, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1