NCT03870100

The PK/PD Study of A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects

Use the Protocol Title. The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study Following A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 45 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This is a Single Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects. The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1222 in healthy subjects including assessment of immunogenicity.

Detailed description

50 adult healthy subjects with 5 dose groups will be enrolled in the study, including six subjects in the lowest dose group, four of whom received the SHR-1209 and two of whom received the placebo. The other three groups have 11 subjects in each group, 9 administered SHR-1222 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	SHR-1222	Pharmaceutical form: water injection Route of administration: subcutaneous
DRUG	Placebo	Pharmaceutical form: water injection Route of administration: subcutaneous

Timeline

• Start date: 2019-04-15
• Primary completion: 2019-10-14
• Completion: 2020-01-06
• First posted: 2019-03-11
• Last updated: 2020-06-16

Locations

1 site across 1 country: China