Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LP-98 Injection in Healthy Subjects

NCT ID: NCT05933824

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-13
• Study Completion Date: 2024-04-12

Brief Summary

A randomized, placebo-controlled, single-administration, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of LP-98 injection in healthy subjects in a first-in-human clinical study

Detailed Description

The study was divided into two parts, Part A and Part B. The Part A and Part B studies were carried out separately according to the protocol flow, with the Part A study carried out first.

1. Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

2. Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PartA:Dose level(5mg)

Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartA:Dose level(10mg)

Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartA:Dose level(20mg)

Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartA:Dose level(40mg)

Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartA:Dose level(80mg)

Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartB:Dose level(5mg)

Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartB:Dose level(10mg)

Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartB:Dose level(20mg)

Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartB:Dose level(40mg)

Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartB:Dose level(80mg)

Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

PartB:Dose level(160mg)

Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

Group Type: EXPERIMENTAL

LP-98 injection

Intervention Type: DRUG

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

Interventions

LP-98 injection

Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

Intervention Type: DRUG

Other Intervention Names

placebo-controlled

Eligibility Criteria

Inclusion Criteria

1. Willing to participate in the study and sign ICF with clear date;

2. Aged 18 to 55 years at the screening visit, male or female;

3. Body weight ≥ 50 kg for males or body weight ≥ 45 kg for females, and body mass index (BMI) within the range of 19 to 28 kg/m2 (inclusive);

4. Be in good health in the PI's judgment, with no clinical significance in previous medical history, laboratory tests, physical examinations, vital signs, and ECG findings;

5. All subjects and his/her partners must agree to use effective non-drug contraception (except for subjects had permanent contraception, i.e., bilateral tubal ligation or vasectomy, etc.) from 2 weeks prior to screening to 3 months after finishing the study. Females must have a negative serum human chorionic gonadotropin (hCG) test for pregnancy confirmation at screening;

6. Willing to comply with the visits, treatments, laboratory tests and other study process required by the protocol.

Exclusion Criteria

1. Allergic to the IP or its excipients, or medicine of the same class , or having a history of severe allergies (including any food allergy or drug allergy);

2. With history or family history of psychiatric, or history of chronic or serious disorders of the central nervous system, cardiovascular, hepatic, nephrological, pulmanory, digestive, metabolic, hematological or skeletal system etc., or definitive history of myelosuppression, orany other significant history of disease that may affect the safety or PK parameters in the PI's judgment;

3. Having positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody;

4. Having clinically significant abnormal results of vital signs or laboratory tests required by the protocol;

5. Having clinically significant abnormality of 12-lead ECG, or having a QTcF interval (using Fridericia's correction) > 450 ms for males or > 470 ms for females;

6. With serum creatine clearance rate (Ccr) < 80 ml/min/1.73 m2 (based on Cockcroft-Gault formula);

7. Known or suspected history of drug abuse (i.e., morphine, methamphetamine, ketamine, dimethylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine etc.), or having positive result for drug abuse;

8. With history of heavy alcohol consumption within 1 year prior to screening (more than 21 units of alcohol per week, i.e., 360 ml of 5% beer, 45 ml of 40% hard liquor, 120 ml of 12% wine, or positive alcohol test;

9. Smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to comply with the prohibition of smoking during the study;

10. Consuming amount > 6 servings of coffee, tea, cola, energy-drink, or other caffeine-containing product per day. One serving ≈ 120 mg of caffeine. Or consumed any caffeine-containing product within 24 hours prior to the dosing of the IP;

11. Had received vaccination within 30 days prior to screening, or planning to receive vaccination during the study;

12. Had received any prescription and non-prescription drugs, herbal remedies, or dietary supplements within 14 days prior to the dosing of the IP;

13. Participated in any other clinical trial within 3 months prior to screening;

14. Had received surgical operation within 3 months prior to screening, or planning to receive surgical operation during the study;

15. Currently pregnant or lactating women；

16. Had blood donation or blood loss over 200 mL within 3 months prior to screening, or planning to donate blood during the study；

17. Cannot tolerate venipuncture blood collection and/or have a history of blood or needle sickness

18. Other conditions considered to be ineligible for study entry in the PI's judgment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Shanxi Kangbao Biological Product Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuang Li, Master

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)

Locations

Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)

Zhengzhou, Henan, China

Countries

China

Other Identifiers

KB_LP-98_101

Identifier Type: -

Identifier Source: org_study_id