NCT03740555

Brief Summary

The purpose of this First-in-Human study is to evaluate the safety , tolerability and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2018

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 9, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

November 9, 2018

Last Update Submit

September 18, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • Number of subjects with adverse events

    To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of adverse events

    Between screening and 7 days after the last dose

  • Number of subjects with abnormal laboratory

    To evaluate the safety and tolerability of HNC042 in comparison with placebo after single and multiple intravenous dose in healthy subjects in terms of abnormal laboratory

    Between screening and 7days after the last dose

  • Number of subjects with abnormal electrocardiogram

    To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal electrocardiogram

    Between screening and 7 days after the last dose

  • Number of subjects with abnormal physical examination

    To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal physical examination

    Between screening and 7 days after the last dose

  • Number of subjects with abnormal vital signs

    To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal vital signs

    Between screening and 7 days after the last dose

Secondary Outcomes (2)

  • The amount of HNC042 in plasma

    Between Day 1 predose and 24 hours after the (last) dose

  • The amount of HNC042 in urine

    Between Day 1 predose and 24 hours after the (last) dose

Study Arms (4)

HNC042 single dose

EXPERIMENTAL

HNC042,freeze-dried powder,single ascending doses Single dose,

Drug: HNC042 single dose

Placebo single dose

PLACEBO COMPARATOR

Placebo single ascending doses , Intravenous route Single dose

Drug: Placebo single dose

HNC042 multiple ascending doses

EXPERIMENTAL

HNC042,freeze-dried powder,multiple ascending doses, Intravenous route

Drug: HNC042 multiple ascending doses

Placebo, multiple ascending doses

PLACEBO COMPARATOR

Placebo, multiple ascending doses, Intravenous route,

Drug: Placebo multiple ascending doses

Interventions

HNC042 single doseDRUG

HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg

HNC042 single dose
Placebo single doseDRUG

Placebo single ascending doses , Intravenous route Single dose, matching placebo

Placebo single dose
HNC042 multiple ascending dosesDRUG

HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg

HNC042 multiple ascending doses
Placebo multiple ascending dosesDRUG

Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo

Placebo, multiple ascending doses

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer, age 18-56 years
  • BMI between 18-34 kg/m2,and body weight not less than 50.0kg.

You may not qualify if:

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paolo B. DePetrillo

Baltimore, Maryland, 21201, United States

Location

Study Design

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

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 14, 2018

Study Start

November 9, 2018

Primary Completion

July 19, 2019

Study Completion

July 19, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

US(1)