Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlexion Pharmaceuticals, Inc.

About this trial

The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Baseline immunoglobulin G (IgG) concentrations ≥ 1000 milligrams per deciliter (mg/dL) and ≤ 1600 mg/dL at Screening.

Antibody titers for Tetanus toxoid (≥ 0.1 International Units per milliliter (IU/mL)) at Screening.

Nonsmokers and not using any nicotine-containing products. A nonsmoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening.

Disqualifiers

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.

Abnormal blood pressure (BP) (resting BP not to exceed 140/80 mmHg and no less than 90/60 mmHg).

Participants who have history of allergy or hypersensitivity to excipients in ALXN2230.

History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 90 days prior to dosing on Day 1.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALXN2230

    Drug

    Participants will receive ALXN2230 via SC injection. Optional cohort will receive ALXN2230 via SC infusion.

  • Placebo

    Drug

    Participants will receive placebo via SC injection. Optional cohort will receive placebo via SC infusion.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ALXN2230Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Time frame
Day 1 up to Day 113

Secondary outcomes

1

Maximum Observed Serum Concentration (Cmax) of ALXN2230

Time frame
Day 1 up to Day 113
2

Time to Cmax (Tmax) of ALXN2230

Time frame
Day 1 up to Day 113
3

Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUCt) of ALXN2230

Time frame
Day 1 up to Day 113
4

Serum Concentration of Biomarkers

Time frame
Day 1 up to Day 113

Other outcomes

Sponsors and contacts

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