A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2022-12-31

Brief Summary

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This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects

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Detailed Description

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108 healthy adult subjects (including 72 subjects in Part A to C, 16-24 subjects in Part D, and 8-12 subjects in optional Part E), including both males and females, will be enrolled in the phase I study.

This study will include Five parts: SSD8432 single dose and SSD8432 co-administrated with ritonavir (Part A), SSD8432 multiple dose (Part B), SSD8432 co-administrated with ritonavir multiple dose (Part C), SSD8432 co-administered ritonavir single dose in fasting and postprandial states (Part D: assessment of food effects) and optional part (Part E: Assessment of the safety and pharmacokinetics of SSD8432 in white healthy adult subjects)

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SSD8432 dose 1~7

Dose level 1 \~7 of SSD8432

Group Type EXPERIMENTAL

SSD8432 dose 1~7 and Ritonavir

Intervention Type DRUG

Cohort 1 Period 1 single dose of SSD8432 dose 1 or placebo, on day 1. Period 2: single dose of SSD8432 dose 2 or placebo , on day 7. Period 3: single dose of SSD8432 dose 3 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date

Cohort 2:

Period 1 single dose of SSD8432 dose 4 or placebo, on day 1 Period 2: single doses of SSD8432 dose 5 or placebo , on day 7 Period 3: single dose of SSD8432 dose 6 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date

Cohort 3:

single dose of SSD8432 dose 7 or placebo on day1. ritonavir or placebo, before SSD8432 dose 7 and BID on SSD8432 dosing date.

SSD8432 dose 8~9

Dose level 8 \~9 of SSD8432

Group Type EXPERIMENTAL

SSD8432 dose 8~9

Intervention Type DRUG

Cohort 4: SSD8432 dose 8 or placebo, on day 1 \~day6. Cohort 5: SSD8432 dose 9 or placebo, on day 1 \~day6.

SSD8432 dose 10~12

Dose level 10 \~12 of SSD8432

Group Type EXPERIMENTAL

SSD8432 dose 10~12 and ritonavir

Intervention Type DRUG

Cohort 6: SSD8432 dose 10 or placebo, on day 1 \~day6. Cohort 7: SSD8432 dose 11 or placebo, on day 1 \~day6. Cohort 8: SSD8432 dose 12 or placebo, on day 1 \~day6 Cohort 9: to be decided

SSD8432 dose 13

Dose level 13 of SSD8432

Group Type EXPERIMENTAL

SSD8432 dose 13 and Ritonavir

Intervention Type DRUG

Cohort 10:

Group A: SSD8432 dose 13, on day1 under fasting condition, on day 6 under fatty food condition, ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date.

Group B: SSD8432 dose 13, on day1 fatty food condition, on day 6 under fasting condition ,Ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date

SSD8432 dose 14

Dose level 14 of SSD8432

Group Type EXPERIMENTAL

SSD8432 dose 14 and Ritonavir

Intervention Type DRUG

Cohort 11: to be decided

Interventions

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SSD8432 dose 1~7 and Ritonavir

Cohort 1 Period 1 single dose of SSD8432 dose 1 or placebo, on day 1. Period 2: single dose of SSD8432 dose 2 or placebo , on day 7. Period 3: single dose of SSD8432 dose 3 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date

Cohort 2:

Period 1 single dose of SSD8432 dose 4 or placebo, on day 1 Period 2: single doses of SSD8432 dose 5 or placebo , on day 7 Period 3: single dose of SSD8432 dose 6 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date

Cohort 3:

single dose of SSD8432 dose 7 or placebo on day1. ritonavir or placebo, before SSD8432 dose 7 and BID on SSD8432 dosing date.

Intervention Type DRUG

SSD8432 dose 8~9

Cohort 4: SSD8432 dose 8 or placebo, on day 1 \~day6. Cohort 5: SSD8432 dose 9 or placebo, on day 1 \~day6.

Intervention Type DRUG

SSD8432 dose 10~12 and ritonavir

Cohort 6: SSD8432 dose 10 or placebo, on day 1 \~day6. Cohort 7: SSD8432 dose 11 or placebo, on day 1 \~day6. Cohort 8: SSD8432 dose 12 or placebo, on day 1 \~day6 Cohort 9: to be decided

Intervention Type DRUG

SSD8432 dose 13 and Ritonavir

Cohort 10:

Group A: SSD8432 dose 13, on day1 under fasting condition, on day 6 under fatty food condition, ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date.

Group B: SSD8432 dose 13, on day1 fatty food condition, on day 6 under fasting condition ,Ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date

Intervention Type DRUG

SSD8432 dose 14 and Ritonavir

Cohort 11: to be decided

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 28 kg/m2.
* Female participants of child-bearing potential must agree to use adequate contraception from screening until 1 months after last dose.

Exclusion Criteria

* History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders), or use of medication that, in the opinion of the Principal Investigator, may not suitable for participating in this study.
* Subjects with a history of hematophobia or trypanophobia and unable to tolerate intravenous indwelling needle blood sampling.
* History of dysphagia or any other gastrointestinal disease possibly affecting drug absorption.
* Take special diet and cannot abide by the provided food and corresponding requirements in this study.
* Subject with a history of clinically significant hypersensitivity reactions to the active substance of SSD8432 or ritonavir or to any other components of drug products.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes