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Nuclear Import Inhibitor

iCP-NI for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Cellivery Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index between 18.0 and 32.0 kg/m2, inclusive.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1, day 7 (pre-am dose) and follow up (day 28 + 2 days)
Awards & highlights

Study Summary

This trial tests a new drug on healthy people to see if it's safe & effective.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body mass index (BMI) falls between 18.0 and 32.0 kg/m2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -1, follow up (day 7) and immunogenicity visit (day 28 + 2 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1, follow up (day 7) and immunogenicity visit (day 28 + 2 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence and severity of adverse events (AEs)
Part A: Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Part A: Number of participants with abnormal 12-lead ECG parameters
+7 more
Secondary outcome measures
Part A: Pharmacokinetics (PK): Accumulation ratio based on AUC0-τ (ARAUC) of iCP-NI
Part A: Pharmacokinetics (PK): Apparent terminal elimination half life (t1/2) of iCP-NI
Part A: Pharmacokinetics (PK): Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-∞) of iCP-NI
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: iCP-NIExperimental Treatment1 Intervention
Part A will comprise a single dose, sequential group design. Part A: 40 subjects will be studied in 5 groups (Groups A1 to A5). In each of Groups A1 to A5, 6 subjects will receive iCP-NI and 2 subjects will receive placebo. Part A: Five proposed dose levels per protocol. Part B will comprise a multiple dose, sequential group design. Part B: 24 subjects will be studied in 3 groups (Groups B1 to B3). In each of Groups B1 to B3, 6 subjects will receive iCP-NI and 2 subjects will receive placebo. Part B: Proposed dose levels to be determined following review of available data from Part A.
Group II: PlaceboPlacebo Group1 Intervention
Part A will comprise a single dose, sequential group design. Part A: 40 subjects will be studied in 5 groups (Groups A1 to A5). In each of Groups A1 to A5, 6 subjects will receive iCP-NI and 2 subjects will receive placebo. Part A: Five proposed dose levels per protocol. Part B will comprise a multiple dose, sequential group design. Part B: 24 subjects will be studied in 3 groups (Groups B1 to B3). In each of Groups B1 to B3, 6 subjects will receive iCP-NI and 2 subjects will receive placebo. Part B: Proposed dose levels to be determined following review of available data from Part A.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Labcorp Drug Development IncIndustry Sponsor
16 Previous Clinical Trials
3,121 Total Patients Enrolled
Cellivery Therapeutics, Inc.Lead Sponsor
Labcorp Corporation of America Holdings, IncIndustry Sponsor
18 Previous Clinical Trials
4,161 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to participants aged 45 and above in this trial?

"The minimum age for inclusion in this medical trial is 18, while the upper limit of eligibility is 55."

Answered by AI

Is recruitment still open for participation in this experiment?

"The information available on clinicaltrials.gov indicates that this medical trial is still underway, with the initial posting occurring on January 19th 2023 and most recent edits made to it taking place on February 21st 2023."

Answered by AI

Is iCP-NI an acceptable form of treatment with no adverse effects?

"Due to the limited prior data available, our team at Power rated iCP-NI's safety with a score of 1 on a scale from 1 to 3."

Answered by AI

How many individuals is this experiment involving?

"Affirmative. The clinical trial, which was originally listed on the 19th of January 2023 is presently recruiting participants; with an update posted as recently as the 21st of February 2023. 64 patients needs to be enrolled at one medical centre for this study's success."

Answered by AI

Are there any specific criteria for persons wishing to contribute to this research?

"This trial seeks to enrol 64 individuals, aged 18-55. Candidates must be of any race and have a BMI between 18.0-32.0 kg/m2; they must also demonstrate general health through medical history, physical examination, ECG testing and vitals. Females are eligible if postmenopausal or permanently sterile (hysterectomy etc.), while males need to use contraception during the study duration—all participants will sign an ICF consenting to abide by study regulations."

Answered by AI
~30 spots leftby Mar 2025