NCT04497662

Brief Summary

Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects

Trial Health

90
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
2 countries

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 22, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

July 28, 2020

Last Update Submit

May 3, 2021

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • TEAEs following IV dosing

    After single ascending IV doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) IV placebo group

    Up to 65 days post dose

  • TEAEs following SC dosing

    After single ascending SC doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) SC placebo group

    Up to 65 days post dose

Study Arms (2)

KPL-404 (IV Administration)

EXPERIMENTAL
Drug: KPL-404Other: Matching Placebo

KPL-404 (SC Administration)

EXPERIMENTAL
Drug: KPL-404Other: Matching Placebo

Interventions

KPL-404DRUG

humanized IgG4 monoclonal antibody

KPL-404 (IV Administration)KPL-404 (SC Administration)
Matching PlaceboOTHER

Placebo

KPL-404 (IV Administration)KPL-404 (SC Administration)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2

You may not qualify if:

  • Poor peripheral venous access
  • Clinically-significant illness within 4 weeks of dose administration
  • Active or acute infection requiring systemic antibiotic treatment within 2 weeks prior to Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PPD Clinic

Austin, Texas, 78744, United States

Location

Q-Pharm Pty Ltd

Herston, Queensland, 4006, Australia

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 4, 2020

Study Start

October 22, 2019

Primary Completion

January 21, 2021

Study Completion

March 2, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)US(1)