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A Phase 1/1b, Three-Part, Randomised, Placebo-Controlled, Single- and Multiple-Ascending-Dose Studyto Evaluate the Safety, Pharmacokinetics, and Activity of SZN-1326 in Healthy Volunteers and in Subjects with Moderate to Severe Ulcerative Colitis

A Phase 1/1b, Three-Part, Randomised, Placebo-Controlled, Single- and Multiple-Ascending-Dose Studyto Evaluate the Safety, Pharmacokinetics, and Activity of SZN-1326 in Healthy Volunteers and in Subjects with Moderate to Severe Ulcerative Colitis

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000344796
Enrollment
39
Registered
2022-02-24
Start date
2022-05-09
Completion date
2023-11-15
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a first-in-human, randomised, double-blinded, placebo-controlled, study to evaluate the safety, tolerability, PK and PD of SZN-1326 conducted in multiple parts. Parts 1 and 2 will be conducted in Australia and include a single ascending dose part (SAD) and a multiple ascending doses part (MAD) enrolling healthy volunteers (HVs). The primary purpose of the study is to characterise the safety and tolerability of single ascending doses of SZN-1326 in healthy volunteers (HVs).

Interventions

Part 1: Single dose of SZN-1326 via intravenous injection, or subcutaneous injection. Each dose level will be tested within one cohort. Each patient will only be assigned one dose level. Dose cohorts will progress through 25mg IV, 2.5mg IV, .01mg IV, 04mg IV, .1mg IV/SC, .4mg IV/SC, 1mg IV/SC, and two additional doses whose concentration will be determined based on data from the prior cohorts. Progression between cohorts will commence based upon recommendation of the SRC based o

Part 1: Single dose of SZN-1326 via intravenous injection, or subcutaneous injection. Each dose level will be tested within one cohort. Each patient will only be assigned one dose level. Dose cohorts will progress through 25mg IV, 2.5mg IV, .01mg IV, 04mg IV, .1mg IV/SC, .4mg IV/SC, 1mg IV/SC, and two additional doses whose concentration will be determined based on data from the prior cohorts. Progression between cohorts will commence based upon recommendation of the SRC based on its review of safety data after all patients in the preceding cohort have been observed for at least 14 days after dose. All dosing is performed while patients are confined in the clinical trial unit for a period prior and after dosing. Part 2: Multiple Ascending Dose - Healthy Volunteers: Multiple doses of SZN-1326 for a period of 4 weeks via weekly intravenous injection . Part 2 may commence upon recommendation of the SRC based on its review of all safety data available when patients in dose cohort .4mg have been observed for 14 days after last dose. Each patient will only be assigned one dose level. 3 dose cohorts will be tested starting at .1mg and progressing to the highest dose concentration based on data from the SAD, with route of administration also determined by data in the SAD. All dosing is performed while patients are confined in the clinical trial unit for a period prior and after dosing.

Sponsors

Surrozen Operating, Inc.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. Be a healthy male or female adult.

Exclusion criteria

1. Is pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period. 2. Has previously received antibody or biologic therapy whether licensed or investigational (immunoglobulin products, monoclonal antibodies or antibody fragments) within the past 6 months. 3. Has received treatment with any experimental drug within 30 days prior, or within five half-lives, prior to Day 0 visit (Baseline), whichever is longer. 4. Has a history of hyperthyroidism, Paget’s disease, osteomalacia, or a fracture within 4 weeks of Screening. 5. Has a history of a previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis. 6. Has clinically significant abnormalities on ECG. 7. A QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 msec for males and >470 msec for females based on either single or averaged QTcF values of triplicate?ECGs prior to study drug administration (Part 1 only) 8. Has a history of malignant neoplasm, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (>1 year ago) or carcinoma in situ of the uterine cervix (>3 years ago) that has been fully treated and shows no evidence of recurrence. Subjects under evaluation for possible malignancy are not eligible. 9. Has a first degree relative with colorectal cancer.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026