A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05147259
• Collaborator: (none)
• Enrollment: 60
• Arms: 3
• Anticipated Duration (Months): 2.6

Study Details

Study Description

Brief Summary

The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.

Condition or Disease	Intervention/Treatment	Phase
Diabetes in Adults	Drug: HR011408 injection	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
• Anticipated Study Start Date: Nov 29, 2021
• Anticipated Primary Completion Date: Jan 30, 2022
• Anticipated Study Completion Date: Feb 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort one: Low dose Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively	Drug: HR011408 injection; Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Experimental: Cohort two: Medium dose Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively	Drug: HR011408 injection; Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Experimental: Cohort three: high dose Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively	Drug: HR011408 injection; Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.

Outcome Measures

Primary Outcome Measures

1. Incidence and severity of adverse events (AEs) [from Day1 to Day15]

   The incidence of adverse events will be collected and the safety of HR011408 will be assessed

2. Area under the concentration-time curve (AUC) [from 0 to 10 hours after dose administration]

   Area under the concentration-time curve (AUC)

3. Maximum observed concentration (Cmax) [from 0 to 10 hours after dose administration]

   Maximum observed concentration (Cmax)

4. Time to maximum observed concentration (Tmax) [from 0 to 10 hours after dose administration]

   Time to maximum observed concentration (Tmax)

5. Elimination half-life (t1/2) [from 0 to 10 hours after dose administration]

   Elimination half-life (t1/2)

6. Time to 50% maximum observed concentration (time to 50% Cmax) [from 0 to 10 hours after dose administration]

   Time to 50% maximum observed concentration (time to 50% Cmax)

7. Onset of appearance [from 0 to 10 hours after dose administration]

   First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)

Secondary Outcome Measures

1. Assessment of development of Anti-drug Antibodies (ADAs) [from Day1 to Day15 after dose administration]

   Incidence of Anti-drug Antibodies (ADAs) will be assessed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male or female aged 18-55 years(both inclusive) at the time of signing informed consent

2. Body mass index 18.0-26.0kg/m2(both inclusive)

3. Body weight ≥50.0kg(male),≥45.0kg(female)

4. Fasting serum/plasma glucose <6.1mmol/L

Exclusion Criteria:

1. Known or suspected of being allergic to any ingredient in the study drug.

2. Participated in any drug or medical device-related clinical trial within 3 months before screening.

3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration

4. Donated blood within 1 month before screening; or donated blood ≥400 mL or had blood loss ≥400 mL during trauma or major surgery within 3 months before screening.

5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05147259
• Other Study ID Numbers: HR011408-101
• First Posted: Dec 7, 2021
• Last Update Posted: Dec 7, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 7, 2021