NCT04317833

Brief Summary

This is a first-in-human, Phase 1, single-center, randomized, single-blind, placebo-controlled, single dose-escalation study to evaluate the safety, tolerability, PK, PD of SSS17 following oral administration in healthy subjects. Approximately 65 subjects (53 receiving active drug and 12 receiving placebo) will participate in this study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

March 19, 2020

Last Update Submit

March 20, 2020

Conditions

Anemia in Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • AEs

    assessment AEs by frequency, severity

    up to Day14 or 29

Secondary Outcomes (15)

  • Maximum plasma concentration (Cmax) of SSS17

    [ up to 48 hours post-dose]

  • Area under the concentration-time curve (AUC) of plasma concentration of SSS17

    [ up to 48 hours post-dose]

  • Time-to-Cmax (Tmax) of SSS 17

    [ up to 48 hours post-dose]

  • Elimination terminal half-life (t1/2) of SSS17

    [up to 48 hours post-dose]

  • Total amount of SSS17 excreted in urine over 24 hours (Ae0-24)

    only for one cohort (up to 72 hours post-dose)

  • +10 more secondary outcomes

Study Arms (2)

Dose Escalation SSS17

EXPERIMENTAL

Escalating doses of SSS17; single dose administration; different dosage forms (redosing of the SSS17 in one cohort with food on Day15)

Drug: SSS17

Escalation matching Placebo

PLACEBO COMPARATOR

Escalating doses of matching placebo; single dose administration; different dosage forms (redosing of matching placebo in one cohort with food on Day15)

Drug: Placebo

Interventions

SSS17DRUG

SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxia-inducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.

Dose Escalation SSS17
PlaceboDRUG

matched placebo

Escalation matching Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body weight≥50 for male or ≥45 for female, and BMI between 19.0-26.0 kg/m2
  • Good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead ECG, clinical laboratory tests and B-type ultrasound test.
  • Participants of reproductive potential must agree to utilize reliable methods of contraception from screening to 6 months after the last administration of the study intervention. No plan for sperm (or egg) donation or pregnancy.
  • Understand and sign the informed consent.
  • Ability to understand and follow study-related instruction

You may not qualify if:

  • A known allergy to any component of the SSS17 formulation, or allergy history of two kinds of drugs or food
  • Medical history or conditions of digestive system.
  • Female volunteers who are pregnant, menstrual, lactating or menopause with hormone therapy.
  • Eyes diseases, including diabetic retinopathy, age-related macular degeneration.
  • Vascular anomalies.
  • Drug, alcohol or nicotine addiction.
  • Blood donation or bleeding (more than 200 ml). Experience of treatment with EPO or blood transfusion.
  • Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance
  • Abnormal results in test of TIBC, serum iron or ferritin
  • Acute diseases before administration.
  • Other situations that the researcher believes may affect validity judgment or are not suitable for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201203, China

Location

Central Study Contacts

Hongzhou Lu, Ph.D

CONTACT

(021)37990333-5278jigouban@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

May 1, 2020

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

March 23, 2020

Record last verified: 2020-03

Locations

CN(1)