A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5817 when administered subcutaneously (SC) as single and multiple doses in adults who are affected by obesity.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol.

Males or females aged 18-55 years old (inclusive).

Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and electrocardiogram (ECG) results.

Body weight change (difference between the maximum body weight and the minimum body weight within 3 months) of no more than 5 kg within the past 3 months.

Disqualifiers

Known or suspected allergy to any ingredient in the investigational medicinal products or related products; or history of multiple and/or severe allergies to drugs or food, or history of severe anaphylaxis.

History of or suffering from major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune or genitourinary systems, which are not suitable for participation in this study as judged by the investigator.

Subjects who have had severe trauma or undergone major surgical procedures within 6 months before screening, or who plan to undergo surgery during the study.

Subjects who have participated in and used any other clinical trial drugs or medical device treatments within 3 months prior to screening or plan to do so during the study period, or within 5 half-lives of the investigational drug before screening (whichever is longer).

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-5817 Injection

    Drug

    HRS-5817 injection administered subcutaneously (SC).

  • HRS-5817 Injection Placebo

    Drug

    HRS-5817 injection placebo administered subcutaneously (SC).

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: HRS-5817 Injection GroupExperimental treatment 1 intervention
Group B: HRS-5817 Injection Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Time frame
Baseline up to Day 253.

Secondary outcomes

1

Area Under the curve from time 0 to time t (AUC0-t)

Time frame
0 to anticipated 253 days.
2

Area Under the curve from time 0 to infinity (AUC0-∞)

Time frame
0 to anticipated 253 days.
3

Maximum concentration (Cmax)

Time frame
0 to anticipated 253 days.
4

Time to reach maximum concentration (Tmax)

Time frame
0 to anticipated 253 days.

Other outcomes

Sponsors and contacts

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