A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects

• Sponsor: Atridia Pty Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04745104
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 6
• Actual Duration (Months): 12.8
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: SHR-1707; Drug: Placebo	Phase 1

Detailed Description

The study will consist of two parts: Subjects will be randomized to receive SHR-1707 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly Subjects
• Actual Study Start Date: Feb 23, 2021
• Actual Primary Completion Date: Mar 21, 2022
• Actual Study Completion Date: Mar 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SHR-1707 Dose level 1 SHR-1707 or placebo is administered intravenous to young healthy subjects	Drug: SHR-1707; SHR-1707 will be administered through IV infusion; Drug: Placebo; Placebo will be administered through IV infusion
Experimental: SHR-1707 Dose level 2 SHR-1707 or placebo is administered intravenous to young healthy subjects	Drug: SHR-1707; SHR-1707 will be administered through IV infusion; Drug: Placebo; Placebo will be administered through IV infusion
Experimental: SHR-1707 Dose level 3 SHR-1707 or placebo is administered intravenous to young healthy subjects	Drug: SHR-1707; SHR-1707 will be administered through IV infusion; Drug: Placebo; Placebo will be administered through IV infusion
Experimental: SHR-1707 Dose level 4 SHR-1707 or placebo is administered intravenous to young healthy subjects	Drug: SHR-1707; SHR-1707 will be administered through IV infusion; Drug: Placebo; Placebo will be administered through IV infusion
Experimental: SHR-1707 Dose level 5 SHR-1707 or placebo is administered intravenous to young healthy subjects	Drug: SHR-1707; SHR-1707 will be administered through IV infusion; Drug: Placebo; Placebo will be administered through IV infusion
Experimental: SHR-1707 Dose level 3 (Elderly subjects) SHR-1707 or placebo is administered intravenous to Elderly subjects	Drug: SHR-1707; SHR-1707 will be administered through IV infusion; Drug: Placebo; Placebo will be administered through IV infusion

Outcome Measures

Primary Outcome Measures

1. Adverse events [Start of Treatment to end of study (approximately 12 weeks)]

   Incidence and severity of adverse events

Secondary Outcome Measures

1. Pharmacokinetics-AUC0-last [Start of Treatment to end of study (approximately 12 weeks)]

   Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration

2. Pharmacokinetics-AUC0-inf [Start of Treatment to end of study (approximately 12 weeks)]

   Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration

3. Pharmacokinetics-Tmax [Start of Treatment to end of study (approximately 12 weeks)]

   Time to Cmax of SHR-1707

4. Pharmacokinetics-Cmax [Start of Treatment to end of study (approximately 12 weeks)]

   Maximum observed concentration of SHR-1707

5. Pharmacokinetics-CL/F [Start of Treatment to end of study (approximately 12 weeks)]

   Apparent clearance of SHR-1707

6. Pharmacokinetics-Vz/F [Start of Treatment to end of study (approximately 12 weeks)]

   Apparent volume of distribution during terminal phase of SHR-1707

7. Pharmacokinetics-t1/2 [Start of Treatment to end of study (approximately 12 weeks)]

   Terminal elimination half-life of SHR-1707

8. Pharmacokinetics MRT [Start of Treatment to end of study (approximately 12 weeks)]

   Mean residence time of SHR-1707

9. Pharmacodynamics [Start of Treatment to end of study (approximately 12 weeks)]

   Change from baseline of plasma biomarker concentrations

10. Anti-Drug antibody [Start of Treatment to end of study (approximately 12 weeks)]

    The percentage of subjects with positive ADA titers over time for SHR-1707.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,

2. Male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in Part 1 and aged between 55 years and 80 years (inclusive) in Part 2

3. Total body weight of 45_{100 kg (inclusive), with a body mass index (BMI) of 19}32 kg/m2 (inclusive) at screening and baseline

4. Subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects

5. WOCBP agree to take effective contraceptive methods

Exclusion Criteria:

1. Severe injuries or surgeries within 6 months before screening

2. ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits

3. QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline

4. Known history or suspected of being allergic to the study drug.

5. Use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose [The dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use]), or within 5 half-lives

6. Live (attenuated) vaccination within 1 month before screening

7. Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.

8. History of alcohol abuse in the past 12 months of screening

9. History of illicit or prescription drug abuse or addiction within 12 months of screening

10. More than 5 cigarettes daily for 12 months before screening

11. Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening

12. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atridia Pty Limited	Sydney	New South Wales	Australia	2000

Sponsors and Collaborators

• Atridia Pty Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Atridia Pty Ltd.
• ClinicalTrials.gov Identifier: NCT04745104
• Other Study ID Numbers: SHR-1707-I-101-AUS
• First Posted: Feb 9, 2021
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Jul 12, 2022