CompletedPhase 1

A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants

United States231 participantsStarted 2024-08-06

Plain-language summary

The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant has provided informed consent before initiation of any study-specific activities/procedures.
✓. Healthy male or female participants, between 18 and 60 years of age (inclusive)
✓. Body mass index between 18 and 32 kg/m2 (inclusive)

Exclusion criteria

✕. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
✕. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
✕. A QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long QT syndrome at Screening or Check-in.
✕. Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 bpm
✕. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Participants with seasonal allergies will be permitted.
✕. Estimated glomerular filtration rate less than 70 mL/min/1.73 m2
✕. Alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper limit of normal at Screening or Check-in.
✕. Positive hepatitis B or hepatitis C panel (including positive hepatitis B surface antigen \[HBsAg\] and/or positive hepatitis C antibody) and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, negative HBsAg) or prior infection (positive hepatitis B core antibody, positive hepatitis B surface antibody, negative HBsAg) may be included.

What they're measuring

Maximum Plasma Concentration (Cmax) of Rocatinlimab

Timeframe: Up to approximately 112 days

Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab

Timeframe: Up to approximately 112 days

AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab

Timeframe: Up to approximately 112 days

Trial details

NCT IDNCT06438263

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-03

View on ClinicalTrials.gov More Atopic Dermatitis trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant has provided informed consent before initiation of any study-specific activities/procedures.
✓. Healthy male or female participants, between 18 and 60 years of age (inclusive)
✓. Body mass index between 18 and 32 kg/m2 (inclusive)

Exclusion criteria

✕. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
✕. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
✕. A QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long QT syndrome at Screening or Check-in.
✕. Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 bpm
✕. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Participants with seasonal allergies will be permitted.
✕. Estimated glomerular filtration rate less than 70 mL/min/1.73 m2
✕. Alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper limit of normal at Screening or Check-in.
✕. Positive hepatitis B or hepatitis C panel (including positive hepatitis B surface antigen \[HBsAg\] and/or positive hepatitis C antibody) and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, negative HBsAg) or prior infection (positive hepatitis B core antibody, positive hepatitis B surface antibody, negative HBsAg) may be included.

What they're measuring

Maximum Plasma Concentration (Cmax) of Rocatinlimab

Timeframe: Up to approximately 112 days

Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab

Timeframe: Up to approximately 112 days

AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab

Timeframe: Up to approximately 112 days